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Administrative data

Description of key information

No repeated dose toxicity studies were available on Isostearyl aclohol by any route. Read across from a reliable  13 week study with Hexadecanol  gave oral NOAEL of > 4257 mg/kg bw/day (Scientific Associates 1996a)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
4 257 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
NOAEL > 4257 mg/kg/bw/day. Read across from hexadecanol, (Rel 2 study, GLP)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No repeated dose toxicity studies were available on Isostearyl aclohol by any route. Read across from a reliable 13 week study with Hexadecanol gave oral NOAEL of > 4257 mg/kg bw/day (Scientific Associates 1996a) and a 28-day studies with Octadecanol oral NOAEL was > 1000 mg/kg bw/day (Henkel 1986a). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966).

The constituents ofISOSTEARYL ALCOHOL (REPLACE WITH UVCB REGISTRATION NAME WHEN AGREED)share a common chemistry, incorporating an alcohol functional group on an alkyl chain, with C-numbers in the range (C14-C20, predominantly C16-C18). The alkyl structures are predominantly monobranched (methyl or ethyl branching, at or beyond the 6-position) and may be considered ‘essentially linear’.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
NOAEL > 4257 mg/kg/bw/day. Read across from hexadecanol, rel 2 study, GLP.

Justification for classification or non-classification

Based on the available data, Isostearyl alcohol is not classified for specific target organ toxicity-repeated exposure under Regulation (EC) No. 1272/2008 (CLP) since no adverse effects occurred at <100 mg/kg bw/day, or for danger of serious damage to health by prolonged exposure under Directive 67/548/EEC (DSD) since no adverse effects occurred at <50 mg/kg bw/day.

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